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QUALITY ASSURANCE
m HEALTH AND ACCREDITATION
Dr. ALEX GEORGE Ph. D
THE CATHOLIC HEALTH ASSOCIATION OF INDIA
QUALITY ASSURANCE
IN HEALTH AND ACCREDITATION
Dr. ALEX GEORGE Ph. D
THE CATHOLIC HEALTH ASSOCIATION OF INDIA
© 2002 The Catholic Health Association of India (CHAI)
Produced by
The Catholic Health Association of India (CHAI)
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Secunderabad, 500 009, A.P.
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ACKNOWLEDGEMENT
The
author
acknowledges
Fr
Sebastian
Ousepperampil, Sr Ancy, Fr Peter Castelino
for encouragement and Fr Shobhit Tom for
facilitating the publication of this pamphlet.
Thanks are also due to Dr Adesh Yadav and
Ms Shyama Wilson for Illustrations, Mr A V S
Rao for Page Make-up and Mr P Ganesh for
support in publication.
1.
What is Quality Assurance ?
Quality Assurance (QA) is a system of ensuring that quality of the
products and services are maintained up to certain standards. It is
primarily aimed at serving the consumers/ users who in fact con
stitute the vast majority of the people of any country. Even produc
ers of one commodity will be consuming many other commodities.
Thus it is in the interest of all.
2.
Why Quality Assurance in Health Care ?
QA in health care is on the one hand meant for delivering quality
care to the patients and on the other hand for helping the providers
of care to work up to the professional standards of the period and
thus ensure a clientele by satisfying them with quality. In the case
of health, the hospitals, health centres, diagnostic centres, dispen
saries and the professionals serving there are the providers and
the patients are the users/ consumers.
3.
What are Standards of Health Care ?
There are mainly three types of standards. Structure, Process and
Outcome Standards.
Structure Standards refer to the Infrastructure, Equipment,
other Physical requirements and Personnel
Process standards deal with the methods and procedure of
treatment.
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Outcome standards are concerned with the result of
Patient coming out satisfactorily after treatment
4.
What are the systems to maintain Quality Assurance ?
4.1
Regulation:
In this system the Government controls the delivery of care.
It will appoint and empower certain Government officials to
ensure the delivery of care through a legal machinery. This
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legal machinery may or may not be appealable against in
the law courts of the country. Or sometimes the appeal will
be only to a higher court and that too only with the permis
sion of the legal authorities under the regulatory mechanism
itself. Needless to add that such permissions are rarely
granted.
4.2
Accreditation:
This is a system of self regulation wherein the different pro
fessions attached to the provision of health care and the
health consumers will jointly operate a QA system.
4.3
Hospital Audit:
Hospital Audit is practised in public hospitals run by the
Government. The British National Health System is a promi
nent example. It is operated through the participation of the
different professions attached to public health care institu
tions. User participation in such systems is increasingly be
coming the norm.
5.
Quality Assurance Systems in Developed Countries
United States of America, Canada, UK, Australia, NZ are some of
the countries with strong QA systems. These countries do have
functioning QA systems, which have built up effective procedures
for their operations. Several other prominent countries also have
substantial QA systems in health care.
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6.
Why Quality Assurance of Health Care in India ?
❖
It is meant to serve affordable and feasible quality in health
care to our own people.
❖
The Middle class & the Mass Media have been articulating
this demand for a long time. They were articulating the felt
needs of the people as a whole only, since the private and
voluntary health sector in India has been out of any kind of
controls regarding the quality of their service.
❖
Of late, Health Insurance companies also insist on quality
standards in the institutions they recognise for service pro
vision to their clients, so that their clients get proper medical
care and thereby insurance claims could be reduced.
7.
Private Sector Regulation in Several States
Tamil Nadu, Bihar, MP, Maharashtra, WB, Manipur, Nagaland,
Sikkim and AP are some of the states, which have enacted or are
in the process of enacting legislations to control private health care
institutions. Even small voluntary institutions with few beds or no
beds also come under the purview of these legislation.
8.
Common Features of Private Health Sector Legislation
The common provisions of the legislation mentioned above are :
❖
The enforcement of registration and license (R &
L) for private and voluntary hospitals which will
be given for a specified period mostly after an
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enquiry by the "competent authority"
❖
Expecting the institutions to maintain the R & L by func
tioning as per certain conditions, which are not quite
clear now or are expected to be formulated later.
❖
Breach of provisions of the legislation or of the condi
tions of R & L can lead to a fine of Rs. 500 to Rs.1,00,
000 with or without imprisonment in different states and
also possible suspension I cancellation of registration /
license.
Big hospitals would eliminate the smaller ones.
8.1
Other Features & implications of the Legislation:
A lack of concern for the limitation of access to health
care, which will result from the large scale closure of
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small units by treating them along with the larger ones.
❖
A lack of sensitivity to institutions of small size deliver
ing health care particularly in remote rural areas.
❖
A lack of concern for the voluntary health sector.
❖
A lack of understanding of the innovative Community
Health experiments in the voluntary sector, which are
being carried out by paramedical or lay staff with mini
mum support from the medical profession is also evi
dent in these legislation.
However, some amount of sensitivity to a socially and economi
cally feasible approach to regulating private and voluntary health
institutions and ensuring their quality is also found in a few of these
legislation. But they are neither adequate nor are perhaps the right
measures. Some such measures found in various Bills/ Acts are:
□ The Rules made for the M.P Act exempts institutions
functioning in locations below 50,000 population from
its purview. Though this would certainly keep the mostly
small scale providers operating at that level of popula
tion, it absolves all such institutions from any kind of
accountability regarding quality.
□ The Rules made under the Tamil Nadu Act specifies that
clinics and dispensaries having up to 2 beds will be
granted Registration and License without any inspec
tion of their premises, facilities, personnel records etc. It
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defines a hospital as a place where 3 or more patients
are treated as inpatients with or without surgeries or con
duct deliveries along with or without OP services.
□ The Bihar Bill includes a provision, which gives the pow
ers to the State Government to relax the requirements
for location, accommodation, equipment and personnel
for clinical establishments in rural areas. This bill also
has a clause to fully or partly exempt charitable
organisations from paying registration and license fees.
□ Dispensaries and doctor's clinics without beds are not
included in the purview of the new bill to amend the
Karnataka Act.
□ Dispensaries without beds are exempted from the pur
view of the West Bengal Act also.
□ Some of these legislation also have differential rates for
charging registration and license fees from big and small
institutions.
These measures certainly reflect an understanding of the need to
protect the existing provision in remote rural areas and other places.
They show an awareness of a possible contraction of access on
account of the legislation.
However, in place of such measures, what is necessary is:
Specification, with some flexibility, of the cluster of ser
vices ie., diseases / conditions that can be treated/
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Linked with this is also the question of access and equity.
Pure considerations of technical quality should not seriously
affect access. Fixing up the same standards for large hospi
tals and the smaller hospitals, health centres and dispensa
ries working in remote rural areas with limited economic re
sources and underdeveloped social and economic infra
structure would be extremely unviable for the latter. It would
lead to large scale closure of such smaller units; thus seri
ously affecting whatever access is available.
Issues such as appropriateness, adequacy and relevance
also figure in the above discussion on conceptual catego
ries of standards. However, though they sound apparently
technical in nature they do have strong ethical bearings at
the same time. Certain procedures which are appropriate,
adequate and relevant according to existing scientific knowl
edge may also have side effects or risks attached with them.
The latter bring in the ethical dimension for quality related
judgements.
10.3
Development of Standards
Standards need to be prepared first in a draft form and then
finalised. In the entire exercise professional experts, repre
sentatives of organisations which are going to own and imple
ment those standards and representatives of users in the
form of health consumer organisations or voluntary
organisations in health need to be involved.
Standards developed will be useful if we:
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□
First list out the services; in this case the diseases and
conditions that would be treated at institutions of differ
ent bed strengths.
□
Then develop the process standards that are neces
sary to deliver those services.
□
And simultaneously develop the structure standards that
are necessary to support those processes.
Instead of such an approach, if we go by the conventional
approach of setting standards we will start with setting struc
ture standards for different sizes of hospitals without even
making sure that these structure standards be even put to
use. they can be used only the institutions for which we are
setting the standards do actually deliver the services for
which they are intended. It is for this reason that we insist
that first the services for which standards are to be set in the
health institutions of various sizes should be agreed upon
by the concerned.
After deciding the range of services to be delivered at insti
tutions of different sizes, the next step that is advised is to
set the process standards ie. the various, diagnostic, medi
cal and surgical procedures required to manage the par
ticular disease, condition. Structure are to be considered
mainly as a support to carrying out these procedures and
not in isolation as in the conventional approach.
Some basic structural standards up to a feasible level re
garding the space plan, power, water, human resources etc
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needs to be specified separately. However, the primacy
should remain on the process standards to treat the agreed
upon range of services. Importance of structure standards,
being seen essentially as a support to process standards.
10.4
Resource Raising to Implement Standards
Resources will be required for upgrading the standards even
though we will be aiming at only feasible levels of quality.
Certain minimum items cannot be compromised at institu
tions of different sizes. For raising necessary resources the
institutions will need support from lead/ mother NGOs and
national and international funders. It will be good if the re
lated institutions articulate themselves through certain net
works.
10.5
Forming Accreditation Councils
Accreditation Councils (AC) will be the bodies, which will
implement an Accreditation System (AS). It will be a self
Accreditation Council meets
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regulatory body of relevant professionals, representatives
of the institutions of various sizes and User representatives,
who will constitute an AS,. There could be a state/ regional
AC, with branches/chapters for districts or zones, ie., groups
of districts.
10.6
Standards Implementation
The District Accreditation Council (DAC) or its members will
make a visit to an Accredited Institution once in a Quarter in
the first year of introducing an AS in a district/ state/ region.
The number of visits could be reduced to once in six months
from the next year.
The DAC will observe the actual delivery of care for various
diseases/ conditions and also the structural features of qual
ity such as infrastructure, equipment and personnel. They
will give suggestions, which the concerned institution will be
expected to carry out within a stipulated time. They will also
play an enabling role in facilitating to organise training
programmes etc., for improving the delivery of care. The
release of any equipment/ instruments budgeted, as per the
fund raising programme also will be supervised by them.
For this purpose they will devise certain guidelines to see to
it that equipment requested are actually needed and also
ensure thafthey will be used. The presence of relevant staff
or a written undertaking that the staff will be got trained within
a specified time, for operating the equipment will be taken.
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10.7
Resource Raising For Standards Maintenance
Recurrent costs after the introduction of standards will have
to be met by the concerned institutions. This will necessi
tate them to adopt suitable financing mechanisms. Imple
menting Health Insurance through self - help groups, micro
credit groups or adopting Co -operative Health Care sys
tems are two options.
10.8
Setting up a Health Insurance Scheme
In insurance, pooling of risks and premia of various
persons helps in proving a large amount to help those
who fall ill. Supposing there are 1000 persons in a
Rural Insurance scheme that we set up and each are
paying a premia of Rs.10 per month. Thus the scheme
will be getting 1000X 10X12 = Rs. 1,20, 000 peryear.
But out of the 1000 people in the scheme only 75 may
fall ill in that year. These 75 will thus get the benefit
of health insurance at the rate of: 1,20, 000/ 75 =
Rs.1600 per year, which is 13 times more than the
annual amount paid. This is a very crude example,
which is only meant to illustrate health insurance in
an easily understandable manner. The provision of
benefit can be increased by increasing the number
persons covered by the scheme, by limiting the in
surance package to a few crucial diseases/ conditions
and from the returns out of the investment from the
premia. Insurance scheme can be introduced only in
areas where we have good rapport with the people. It
is better not to be thought of as a scheme to start off
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health activity in an area. Instead it can fit in better,
in areas where we have a health programme, well
embedded in other development programmes. Cen
tres/ institutions having self help groups or micro
credit groups attached to related development
programmes will have an added advantage. Convinc
ing the people about the need to pay regular premium
is relatively less difficult if the organisers of the
scheme are having good rapport with the people for
Contribute a small amount regularly to gain more for treatment while fallig ill.
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whom it is organised. This is ensured in the case of
well developed health and development programmes
having at least a few years of association with the
people for whom a scheme is planned.
10.9
Co - operative Financing
In the scheme of co- operative financing an entry fee is col
lected in bulk at the time of joining. In return to this fee, a
certain number of shares are issued to the member and
these funds are invested. Out of the return from these funds
and also because only few members fall ill at a time, the
scheme will be able to give a certain percentage of discount
in health expenditure incurred at its institutions. The amount
collected as share value could be collected in instalments
also.
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